Vioxx could return to market if benefits outweigh risks

WASHINGTON—Vioxx, the prescription painkiller implicated in the deaths of thousands of Americans and withdrawn from sale in September, may be reintroduced in the market if the Food and Drug Administration concludes that the benefits of the drug outweighs its hazards, an executive for Merck & Co. said Thursday.

Dr. Peter Kim, head of Merck Research Laboratories, made the comments at a special FDA hearing that was called to assess the risks of Cox-2 inhibitors—the family of painkillers that includes Vioxx.

"If the advisory committee and the FDA conclude that the benefits of the class outweigh the risk in some patient populations, then we would have to consider the implications of these new data, given the unique benefits Vioxx offers," he said.

Kim said his company had heard from patients who said Vioxx was the only medication that alleviated their pain. He also said a newly released study suggested that the hazards and benefits of Vioxx are similar to those for Celebrex and Bextra, two other painkillers in its class that remain on the market.

Dr. Alastair Wood, who's chairing the FDA hearings, said afterward that any reintroduction of Vioxx "would be an amazing outcome."

Merck took Vioxx off the market after a study found that patients taking the drug for at least 18 months had twice the risk of cardiovascular disease compared with people not taking the drug.

Studies also have shown that Celebrex and Bextra, made by Pfizer and currently still being sold, may pose an additional risk, although the hazards appear to be less than those of Vioxx.

Meanwhile, the senior safety expert for the FDA who first estimated that Vioxx was killing tens of thousands of Americans, warned Thursday that other commonly used pain medications also are risky.

Dr. David Graham, an FDA epidemiologist, told the panel of medical experts that studies suggest that an older generation of drugs taken for pain and inflammation, such as ibuprofen and indomethacin, also may increase the risks of heart attacks and strokes.

While Graham said preliminary findings suggest the risks of the older drugs were far less than those of Vioxx, he said more studies should be conducted. And he cautioned patients and doctors to be careful when using or prescribing them.

"Let's identify the bad actors and get rid of them," Graham said at the meeting. The panel must decide whether to recommend restricting the use of Cox-2 inhibitors or urge that they be withdrawn from the market.

For all the concern about the potential hazards of Cox-2 drugs, patients with chronic pain and the physicians who treat them told the committees that those medications were all they had in some cases to make them feel better. They urged the committees recommend that they be kept on the market.

"To limit choices based on evolving knowledge is not fair to millions of Americans who suffer arthritis pain," said Dr. W. Hayes Wilson, a rheumatologist from Atlanta. "We must consider both sides of the equation when we decide how to treat patients and what we treat them with. Most of my patients would accept considerable risk if provided with relief from arthritis pain."

Michael Paranzino, head of a group pushing for more psoriasis research, said many patients with psoriasis-related arthritis took Cox-2 inhibitors and believed in their therapeutic value.

"Many ... patients are in a difficult spot, alarmed by the recent reports of apparent risks of these drugs, yet reliant on these medications to maintain their quality of life," Paranzino said.

Some panel members appeared sympathetic to patient advocates, who urged that the panel recommend that the drugs remain on the market.

"We have to factor in the suffering of patients who don't tolerate the traditional" painkillers, said Dr. Steven Nissen, medical director of the Cleveland Clinic Cardiovascular Coordinating Center.

During his remarks to the panel, Graham said Vioxx had the highest risk of all painkillers, including other Cox-2s. In testimony to Congress in November, Graham said as many as 55,000 people may have died from Vioxx's side effects.

Moreover, cardiovascular problems developed in a small number of patients from the moment they began taking the medication, Graham said.

Overall, he said the risk at high doses was "more significant than smoking or diabetes or perhaps a combination of those factors."

Cox-2s have too many harmful effects and too few benefits, he said. "The bottom-line conclusion is that there really does not appear to be a need for Cox-2s."

The advisory committee, composed of medical experts from government, universities and private-sector health care institutions, is expected to make a recommendation Friday on whether to require a warning label on Celebrex and Bextra outlining the problems or urge that they be withdrawn.